BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL BASEPLATE-RM/LL-SZ 5

    MDR report key: 5823307 · Received July 26, 2016

    Report

    Report Number
    3005985723-2016-00231
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    June 29, 2016
    Report Date
    June 29, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICE WAS ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 5; CAT# 180515; LOT# UNKNOWN. MCK TIBIAL ONLAY INSERT-SZ 5-8MM; CAT# 180705-1; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT THE LATER TIME IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REVISION SURGERY OF MCK UNI MEDIAL DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476575 MCK TIBIAL BASEPLATE-RM/LL-SZ 5 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention